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Artificial intelligence

Interplay between medical-device legislation and the EU Artificial Intelligence Act.

Official catalogue · non-binding

Artificial intelligence guidance (1)

Catalogue entries are ordered as they appear in the European Commission catalogue.

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MDCG 2025-6FAQ on Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA)June 2025
Non-binding guidanceOpen guidance page
Catalogue section
New technologies
Published
June 2025
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Source document

  • MDCG 2025-6PDF · Unverified extraction previewOfficial source

    Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.

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